Amendment_0007_Summary_of_Changes.doc

Solicitation FDA-14-223-SOL-00005 Amendment 0007 Summary The purposes of Solicitation FDA-14-223-SOL-00005 Amendment 0007 are as follows: provide clarification on the number of Document Control Centers (DCC) and Document Control Center Facilities as referenced within the IDIQ solicitation, provide clarification on how to complete IDIQ and CBER task order pricing templates, upload revised CDER task order pricing template that includes a tab for ODC’s, clarify due date of proposal.

1. The Government wishes to provide clarification on page 105 of the IDIQ solicitation. The section stated: “The Offeror shall indicate how they will staff each CDER DCC: CDR, MPN, White Oak, and EDR.” EDR is actually part of the White Oak DCC. The section has been revised to read: “The Offeror shall indicate how they will staff each of the three CDER primary Document Control Centers: CDR, White Oak, MPN.”

The Offeror should refer to pages 12 and 13 of the CDER Task Order SOW for a breakdown of the three primary DCC’s and the respective Document Control Center Facilities for each.

2. The Government wishes to reinforce that sufficient equipment will be provided by the Government to support scanning and copying activities identified in the CDER SOW. Notwithstanding, at least one vendor has expressed a desire to add additional ODCs to the price of the task order. Consequently, the Government has created and uploaded a revised Excel spreadsheet titled: “RFPATTACHMENTN06TOPRICINGSHEET140417” that includes a tab for Other Direct Costs applicable to the task order. Offerors are expected to complete the revised spreadsheet as part of their proposal, regardless of whether or not they add additional ODCs to the task order. If ODCs are not needed, leave tab blank. If your firm intends to include ODCs for the option years of the task order, they shall be included on this tab as well. Contractors are also reminded that they are not constrained in any way on the number of hours they propose for the various labor categories listed in the TO Pricing Template. When completing the TO and IDIQ pricing templates, please be sure that the totals from each tab carry forward to the Summary Tab.

3. Note that the fully burdened rate that the Contractor proposes is to be inclusive of the following: Direct labor rate, Overhead, General and Administrative expenses, Profit, Fringe, and Facility Capital Costs. Offerors provide the breakdown of their fully burdened rate on the IDIQ Pricing Sheet, Tab 2, which includes columns for fringe, overhead, G&A, and profit. The proposed fringe rate shall include H&W, payroll taxes, FUTA, FICA, and all other costs that the Contractor incurs as fringe under its approved accounting system. It is the Contractor’s responsibility to ensure that all appropriate fringe is covered. Any program management costs, ODCs etc. that that the Contractor believes apply at the IDIQ level, should also be accounted for in the Offeror’s fully burdened labor rates.

4. The “Prime/Subcontractor Resources” column on the Base Period Tab of RFPATTACHMENTN06TOPRICINGSHEET140417 was included in order to assess compliance with the limitation on subcontracting clause and the 51% rule. It is assumed that the positions identified by the Contractor as prime or sub in the base year will carry forward to the option years as well. Whether a given labor category will be filled by prime contractor employees or by subcontractor employees, the same rate shall be used for each. If the Contractor intends to utilize both prime contractor and subcontractor employees for a given labor category that may require multiple FTE’s, they Contractor should specify in the column how many hours will be completed by the prime contractor employees and how many by the subcontractor employees for that given labor category.

5. Based on the number of Past Performance Questionnaires already received, the number of expected offers received in response to this solicitation is expected to be substantial.

Quotes are due no later than 12:00 p.m. Eastern Time on 24 APRIL 2014.

No Additional Contactor questions shall be answered.

All other terms and conditions remain the same.